DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/26/2026 has been entered.
Response to Arguments
Applicant argues in the response filed 06/26/2026 that the claim amendments would overcome the previous 112 rejections. The previous 112 rejection has been withdrawn.
The applicant argues prior art Gollner in view of Aramaki and Dakin, Houser, and Laufer does not disclose the new limitations with respect to the thermal and pressure weld of the resin cylindrical portion and the biodegradable polymer of the main body portion. The rejection has been withdrawn. A new rejection with respect to Gollner in view of Aramaki and Dakin, Akin, Tallarida, and Houser has been made below.
The applicant argues prior art Dakin in view of Cole, Asfora, and Laufer does not disclose the new limitations with respect to the thermal and pressure weld of the resin cylindrical portion and the biodegradable polymer of the main body portion The rejection has been withdrawn. A new rejection with respect to Dakin in view of Asfora, Akin and Tallarida has been made below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 5, 6, 10, 11, 14, 15, 25 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0316426 to Gollner in view of U.S. Patent Publication 2019/0282235 to Aramaki and U.S. Patent Publication 2009/0036820 to Dakin, U.S. Patent Publication 2003/0100920 to Akin, U.S. Patent Publication 2003/0195504 to Tallarida and in view of and/or as evidenced by U.S Patent 7,182,771 to Houser.
As to claims 1, 10, Gollner discloses a medical device comprising:
a sheet-like main body portion (46);
a cylindrical portion (44) that is disposed closer to a center portion side in a plane direction of the main body portion than an outer peripheral portion in the plane direction of the main body portion (figure 15), the cylindrical portion protruding in a first direction intersecting the plane direction of the main body portion, and a lumen formed in the cylindrical portion (figure 15);
an edge portion (the flange of 44, figure 15, paragraph 82) that is formed integrally with the cylindrical portion (figure 15, paragraph 82 seems to support a continuous unitary structure) and extends to an outer peripheral portion side in the plane direction of the main body portion with respect to the cylindrical portion (figure 15);
a connection portion (45, and/or the means for connecting, paragraph 82) that connects the cylindrical portion and the edge portion with the main body portion (figure 15, paragraph 82),
However, Gollner is silent the about a plurality of through holes are formed in the body portion, the sheet-like main body portion configured to induce expression of biological components by being applied to anastomosis portions of living body organs and promote fusion of the anastomosis portions by allowing the induced biological components to penetrate through the through holes and accumulating the induced biological components, the thickness of the edge portion formed smaller than the thickness of the cylindrical portion, and the connection portion includes a thermal and pressure welded portion in which a resin material forming the cylindrical portion and a biodegradable polymer forming the main body portion are thermal and pressure welded.
Aramaki teaches a similar device (anastomosis device) having sheet like main body (120) including a plurality of through holes (25, paragraph 73) are formed, the sheet-like main body portion configured to induce expression of biological components by being applied to anastomosis portions of living body organs and promote fusion of the anastomosis portions by allowing the induced biological components to penetrate through the through holes and accumulating the induced biological components (paragraph 70) for the purpose of promoting adhesion of the device when placed in contact with tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the main body with the plurality of through holes of Aramaki as the portion 46 of the device of Gollner in order for promoting adhesion of the device when placed in contact with tissue.
Houser teaches a similar device (cylindrical portion) having a thickness of an edge portion formed smaller than the thickness of a cylindrical portion in order to have more flexibility on the periphery (col. 7 ll. 60-63). Houser teaches examples of cylindrical portions that have a thicker central portion than a periphery section (130, figure 12). Dakin teaches a similar device (implantable connecting device, abstract) also teaches a thickness of an edge portion formed smaller than the thickness of a cylindrical portion (figure 1a). The varying thickness can reinforce the central tubular portion and allow the periphery to be flexible to secure to the other lumens. It can be obvious to have the central section of Gollner be thicker than the edge portion which can help to reinforce the central portion. Houser can provide evidence that it is known to have a thicker central tubular portion. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the thickness of the edger portion of Gollner formed smaller than the thickness of the cylindrical portion in order to reinforce the cylindrical portion but increase flexibility in the edge portion.
Gollner discloses the device can be made of different materials, including plastics (paragraph 18). Akin teaches a similar device (implantable conduit device, abstract) having comprising a variety of materials including silicones and biodegradable polymers (paragraph 196,198) for the purpose of selecting a material for the benefit of its intended use. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a resin material for the cylindrical portion and a biodegradable polymer for the main body portion since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Gollner discloses the components of the embodiment of figure can be bonded (paragraph 82) and that different parts of a device can be welded to one another (paragraph 16). Tallarida teaches thermal and pressure welding enhances the bond between segments of a device (paragraph 56). It would have been obvious to one of ordinary skill in the art before the effective filing date to use a thermal and pressure welded portion as the connection portion between the resin cylindrical portion and the biodegradable polymer main body portion in order for enhancing bonding between the segments.
Gollner does disclose that the main body portion 46 is a cloth ring, the cylindrical portion and the connecting portion is made of a harder material (paragraph 82, 18). However, Gollner is silent about a relationship among hardness of the cylindrical portion, hardness of the connection portion, and hardness of the main body portion satisfies expression (1): hardness of cylindrical portion > hardness of connection portion > hardness of main body portion (1). Dakin teaches a similar device (implantable connecting device, abstract) having a device where rigidity decreases in an increasing radially direction in order to allow for deflection as desired (paragraph 84). This helps to deploy and secure the device in place. Therefore, the hardness of the main body portion, cylindrical portion, and connecting portion of Gollner can be selected to allow the device to be deflected as desired. The hardness of the components of the device will be a result effective variable in that the hardness can be selected for the components of the device in order easily and smoothly handle and deploy the device as desired. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Gollner to have the hardness of the components be within the claimed expressions as it involves only adjusting the characteristics of a material component used. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Gollner by making the relationship among hardness of the cylindrical portion, hardness of the connection portion, and hardness of the main body portion satisfies expression (1): hardness of cylindrical portion > hardness of connection portion > hardness of main body portion (1) as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claims 2, 11, the device of Gollner as modified by Aramaki, Dakin, Houser, Akin, and Tallarida discloses the device above but is silent about a relationship among a degree of elongation of the cylindrical portion, a degree of elongation of the connection portion, and a degree of elongation of the main body portion in the first direction satisfies expression (2): degree of elongation of cylindrical portion < degree of elongation of connection portion < degree of elongation of main body portion (2); and a relationship among a degree of contraction of the cylindrical portion, a degree of contraction of the connection portion, and a degree of contraction of the main body portion in the first direction satisfies expression (3): degree of contraction of cylindrical portion > degree of contraction of connection portion > degree of contraction of main body portion (3). Dakin does teach that components of the device can have different characteristic in order to allow for bending while also preventing pull-out of the device as desired (paragraph 84). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Gollner to have relationship among a degree of elongation of the cylindrical portion, a degree of elongation of the connection portion, and a degree of elongation of the main body portion within the claimed expression as it involves only adjusting known characteristics of a component used. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Gollner, Aramaki, Dakin, Houser, Akin, and Tallarida by making the relationship among a degree of elongation of the cylindrical portion, a degree of elongation of the connection portion, and a degree of elongation of the main body portion in the first direction satisfies expression (2): degree of elongation of cylindrical portion < degree of elongation of connection portion < degree of elongation of main body portion (2); and a relationship among a degree of contraction of the cylindrical portion, a degree of contraction of the connection portion, and a degree of contraction of the main body portion in the first direction satisfies expression (3): degree of contraction of cylindrical portion > degree of contraction of connection portion > degree of contraction of main body portion (3) as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claims 5, 14, the device of Gollner as modified by Aramaki, Dakin, Houser, Akin, and Tallarida discloses the device above but is silent about a relationship among hardness of the cylindrical portion, hardness of the edge portion, hardness of the connection portion, and hardness of the main body portion satisfies expression (4): hardness of cylindrical portion 2 hardness of edge portion > hardness of connection portion > hardness of main body portion (4); in a second direction from a center portion side of the main body portion toward an outer peripheral portion side of the main body portion, a relationship among a degree of elongation of the cylindrical portion, a degree of elongation of the edge portion, a degree of elongation of the connection portion, and a degree of elongation of the main body portion satisfies expression (5): degree of elongation of cylindrical portion < degree of elongation of edge portion < degree of elongation of connection portion < degree of elongation of main body portion (5); and a relationship among a degree of contraction of the cylindrical portion, a degree of contraction of the edge portion, a degree of contraction of the connection portion, and a degree of contraction of the main body portion in the second direction satisfies expression (6): degree of contraction of cylindrical portion = degree of contraction of edge portion > degree of contraction of connection portion > degree of contraction of main body portion (6). Dakin does teach that components of the device can have different characteristic in order to allow for bending while also preventing pull-out of the device as desired (paragraph 84). The hardness ratios and degree of elongation and contraction of the device can be adjusted to what extend deformation is allowed and for easy delivery and deployment of the device. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Gollner to have hardness ratios and degrees of elongation/contracting be with within the claimed expression as it involves only adjusting known characteristics of a component used. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Gollner, Aramaki, Dakin, Houser, Akin, and Tallarida by making the relationship among hardness of the cylindrical portion, hardness of the edge portion, hardness of the connection portion, and hardness of the main body portion satisfies expression (4): hardness of cylindrical portion 2 hardness of edge portion > hardness of connection portion > hardness of main body portion (4); in a second direction from a center portion side of the main body portion toward an outer peripheral portion side of the main body portion, a relationship among a degree of elongation of the cylindrical portion, a degree of elongation of the edge portion, a degree of elongation of the connection portion, and a degree of elongation of the main body portion satisfies expression (5): degree of elongation of cylindrical portion < degree of elongation of edge portion < degree of elongation of connection portion < degree of elongation of main body portion (5); and a relationship among a degree of contraction of the cylindrical portion, a degree of contraction of the edge portion, a degree of contraction of the connection portion, and a degree of contraction of the main body portion in the second direction satisfies expression (6): degree of contraction of cylindrical portion = degree of contraction of edge portion > degree of contraction of connection portion > degree of contraction of main body portion (6) as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claims 6, 15, with the device of Gollner, Aramaki, Dakin, Houser, Akin, and Tallarida above, Gollner discloses the cylindrical portion is disposed in a range including a center portion of the main body portion in the plane direction (figure 16).
As to claim 25 Gollner as modified by Aramaki, Dakin, Houser, Akin, and Tallarida discloses the device above but is silent about the resin material of the cylindrical portion is a silicone elastomer. Gollner discloses components of the device can be made of a multitude of materials including silicone (paragraph 18, 32, 55). Akin further teaches the use of a silicone elastomer (paragraph 196). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the resin material of the cylindrical portion be a silicone elastomer since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Claims 1, 2, 5-8, 10, 11, 14-17, 21, 25 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2009/0036820 to Dakin in view of U.S. Patent 8,361,092 to Asfora, U.S. Patent Publication 2003/0100920 to Akin, and U.S. Patent Publication 2003/0195504 to Tallarida.
As to claims 1, 10, Dakin discloses a medical device comprising:
a sheet-like main body portion (144/126 of 102, figure 1a,b);
a cylindrical portion (130) that is disposed closer to a center portion side in a plane direction of the main body portion than an outer peripheral portion in the plane direction of the main body portion (figure 1a,b, 15), the cylindrical portion protruding in a first direction intersecting the plane direction of the main body portion, and a lumen formed in the cylindrical portion (figure 1a,b, 15);
an edge portion (the circular portion where the cylindrical portion merges into the flange, that comprises 118, figure 1a,b, paragraph 84, 86) that is formed integrally with the cylindrical portion (figure 1a,b, the structure is continuous as seen in the figures) and extends to an outer peripheral portion side in the plane direction of the main body portion with respect to the cylindrical portion (figure 1a,b); the thickness of the edge portion formed smaller than the thickness of the cylindrical portion (figure 1,a,b the central portions seems to have a greater thickness than the edge portion).
However, Dakin is silent the about a plurality of through holes are formed in the body portion, the sheet-like main body portion configured to induce expression of biological components by being applied to anastomosis portions of living body organs and promote fusion of the anastomosis portions by allowing the induced biological components to penetrate through the through holes and accumulating the induced biological components, a connection portion that connects the cylindrical portion and the edge portion with the main body portion, the connection portion includes a thermal and pressure welded portion in which a resin forming the cylindrical portion and a biodegradable polymer forming the main body portion are thermal and pressure welded.
Asfora teaches a similar device (anastomosis device) having sheet like main body (20, figure 22) including a plurality of through holes (74, col. 12 ll. 9-30) are formed, the sheet-like main body portion configured to induce expression of biological components by being applied to anastomosis portions of living body organs and promote fusion of the anastomosis portions by allowing the induced biological components to penetrate through the through holes and accumulating the induced biological components (the through holes allow the promotion of growth through the perforations and therefore can be configured to induce the expression of biological components) for the purpose of helping to promote a reliable seal. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the through holes of Asfora in the main body of Dakin in order to promote a reliable seal.
Dakin discloses parts of the device can be silicone and resorbable (paragraph 110, 111). Akin teaches a similar device (implantable conduit device, abstract) having comprising a variety of materials including silicones and biodegradable polymers (paragraph 196,198) for the purpose of selecting a material for the benefit of its intended use. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a resin material for the cylindrical portion and a biodegradable polymer for the main body portion since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Dakin discloses teaches the body portion and the cylindrical portion, but not how the portions are connected. Tallarida teaches thermal and pressure welding enhances the bond between segments of a device (paragraph 56).The welding can comprise the connecting portion. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a thermal and pressure welded portion as a connection portion between the resin cylindrical portion and the biodegradable polymer main body portion in order for enhancing bonding between the segments.
Dakin is silent about a relationship among hardness of the cylindrical portion, hardness of the connection portion, and hardness of the main body portion satisfies expression (1): hardness of cylindrical portion > hardness of connection portion > hardness of main body portion (1). Dakin does disclose the rigidity decrease in a radially increasing direction in order to optimize deflection and strength as desired. The hardness ratio between the sheet-like main body, cylinder portion, and connection that satisfies the formula (1) above can be result effective variable in that hardness can be selected to optimize deflection and strength as desired. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Dakin to have the hardness of the components be within the claimed expressions as it involves only adjusting the characteristics of a material component used. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Dakin by making the relationship among hardness of the cylindrical portion, hardness of the connection portion, and hardness of the main body portion satisfies expression (1): hardness of cylindrical portion > hardness of connection portion > hardness of main body portion (1) as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claims 2, 11, the device of Dakin as modified by Asfora, Akin, and Tallarida discloses the device above but is silent about a relationship among a degree of elongation of the cylindrical portion, a degree of elongation of the connection portion, and a degree of elongation of the main body portion in the first direction satisfies expression (2): degree of elongation of cylindrical portion < degree of elongation of connection portion < degree of elongation of main body portion (2); and a relationship among a degree of contraction of the cylindrical portion, a degree of contraction of the connection portion, and a degree of contraction of the main body portion in the first direction satisfies expression (3): degree of contraction of cylindrical portion > degree of contraction of connection portion > degree of contraction of main body portion (3). Dakin does disclose that components of the device can have different characteristic in order to allow for bending while also preventing pull-out of the device as desired (paragraph 84). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Dakin to have relationship among a degree of elongation of the cylindrical portion, a degree of elongation of the connection portion, and a degree of elongation of the main body portion within the claimed expression as it involves only adjusting known characteristics of a component used. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Dakin, Asfora, Akin and Tallarida by making the relationship among a degree of elongation of the cylindrical portion, a degree of elongation of the connection portion, and a degree of elongation of the main body portion in the first direction satisfies expression (2): degree of elongation of cylindrical portion < degree of elongation of connection portion < degree of elongation of main body portion (2); and a relationship among a degree of contraction of the cylindrical portion, a degree of contraction of the connection portion, and a degree of contraction of the main body portion in the first direction satisfies expression (3): degree of contraction of cylindrical portion > degree of contraction of connection portion > degree of contraction of main body portion (3) as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claims 5, 14, the device of Dakin as modified by Asfora, Akin and Tallarida discloses the device above but is silent about a relationship among hardness of the cylindrical portion, hardness of the edge portion, hardness of the connection portion, and hardness of the main body portion satisfies expression (4): hardness of cylindrical portion 2 hardness of edge portion > hardness of connection portion > hardness of main body portion (4); in a second direction from a center portion side of the main body portion toward an outer peripheral portion side of the main body portion, a relationship among a degree of elongation of the cylindrical portion, a degree of elongation of the edge portion, a degree of elongation of the connection portion, and a degree of elongation of the main body portion satisfies expression (5): degree of elongation of cylindrical portion < degree of elongation of edge portion < degree of elongation of connection portion < degree of elongation of main body portion (5); and a relationship among a degree of contraction of the cylindrical portion, a degree of contraction of the edge portion, a degree of contraction of the connection portion, and a degree of contraction of the main body portion in the second direction satisfies expression (6): degree of contraction of cylindrical portion = degree of contraction of edge portion > degree of contraction of connection portion > degree of contraction of main body portion (6). Dakin does disclose that components of the device can have different characteristic in order to allow for bending while also preventing pull-out of the device as desired (paragraph 84). The hardness ratios and degree of elongation and contraction of the device can be adjusted to what extend deformation is allowed and for easy delivery and deployment of the device. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Dakin to have hardness ratios and degrees of elongation/contracting be with within the claimed expression as it involves only adjusting known characteristics of a component used. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Dakin, Asfora, Akin, and Tallarida by making the relationship among hardness of the cylindrical portion, hardness of the edge portion, hardness of the connection portion, and hardness of the main body portion satisfies expression (4): hardness of cylindrical portion 2 hardness of edge portion > hardness of connection portion > hardness of main body portion (4); in a second direction from a center portion side of the main body portion toward an outer peripheral portion side of the main body portion, a relationship among a degree of elongation of the cylindrical portion, a degree of elongation of the edge portion, a degree of elongation of the connection portion, and a degree of elongation of the main body portion satisfies expression (5): degree of elongation of cylindrical portion < degree of elongation of edge portion < degree of elongation of connection portion < degree of elongation of main body portion (5); and a relationship among a degree of contraction of the cylindrical portion, a degree of contraction of the edge portion, a degree of contraction of the connection portion, and a degree of contraction of the main body portion in the second direction satisfies expression (6): degree of contraction of cylindrical portion = degree of contraction of edge portion > degree of contraction of connection portion > degree of contraction of main body portion (6) as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claims 6, 15, with the device of Dakin, Asfora, Akin, and Tallarida, above, Dakin discloses the cylindrical portion is disposed in a range including a center portion of the main body portion in the plane direction (figure 1a,b).
As to claims 7, 16, with the device of Dakin, Asfora, Akin, and Tallarida above, Dakin discloses, in another embodiment, a first reinforcing portion (portion of 118 near 122, figure 1c) that is disposed closer to an outer peripheral portion in the plane direction of the main body portion than the cylindrical portion and has a hardness greater than the hardness of the main body portion; and a second reinforcing portion (portion of 118 near 121, figure 1c) that is disposed closer to the outer peripheral portion in the plane direction of the main body portion than the first reinforcing portion (figure 1c) and has a hardness greater than the main body portion. Dakin teaches that the tips can be shaped to reinforce the device and that the outer portion can be elongated on one side to help minimize resistance (paragraph 87). Based on the hardness ratio of claims 1, 10, the hardness of the tips of 118 will have a hardness greater than the main body portion. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the embodiment of Dakin above include the first and second reinforcing portions in order to help reinforce the device, minimize resistance, and secure the device in place.
As to claims 8, 17, with the device of Dakin, Asfora, Akin, and Tallarida above, Dakin discloses the cylindrical portion is connected to one of a front surface of the main body portion and a back surface of the main body portion (figure 1a-f); and a space portion recessed in a convex shape toward the one surface side is formed on the other surface side opposite to the one surface to which the cylindrical portion is connected in a range overlapping with a position to which the cylindrical portion is connected in plan view (figure 1a-f).
As to claim 21, with the device of Dakin, Asfora, Akin, and Tallarida above, Dakin discloses the lumen formed in the cylindrical portion does not have a constant shape along an axial direction of the cylindrical portion (figure 13, 14). If it would not beknown that the non-constant lumen shape can be used in the embodiment of Dakin as rejected above, it would have been obvious in order to improve flow through the lumen (paragraph 101).
As to claim 25, with the device of Dakin, Asfora, Akin, and Tallarida above, Akin teaches the device can be made of a multitude of materials including silicone (paragraph 196). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the resin material of the cylindrical portion be a silicone elastomer since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Claims 9, 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0316426 to Gollner in view of U.S. Patent Publication 2019/0282235 to Aramaki and U.S. Patent Publication 2009/0036820 to Dakin, U.S. Patent Publication 2003/0100920 to Akin, U.S. Patent Publication 2003/0195504 to Tallarida and in view of and/or as evidenced by U.S Patent 7,182,771 to Houser as applied to claims 1, 2, 5, 6, 10, 11, 14, 15, 25 above, and further in view of U.S. Patent Publication 2005/0149073 to Arani and/or in view of or as evidenced by U.S. Patent 6,030,395 to Nash.
As to claims 9, 18, Gollner as modified by Aramaki, Dakin, Houser, Akin, and Tallarida discloses the device above but is silent a cross-sectional shape of a lumen of the cylindrical portion is different between one end portion of the cylindrical portion located along the first direction and the other end portion located on an opposite side of the one end portion, and the one end portion has a larger inner diameter than the other end portion.
Arani teaches a similar device (anastomosis device, abstract) having a having a cross-sectional shape of a lumen of a cylindrical portion (14) is different between one end portion of the cylindrical portion located along the first direction and the other end portion located on an opposite side of the one end portion (figure 1c), and the one end portion has a larger inner diameter than the other end portion (figure 1c). The larger inner diameter at one end compared to the other will help optimize the flow of fluid therethrough from one vessel into the other. Nash teaches a similar device (anastomosis device, abstract) that has a passageway which tapers one end in order to reduce any turbulence in the flow therethrough. The cylindrical portion of Gollner that has a tubular portion with an annular ridge, similar to that of Arani, can have the different cross sections with a greater inner diameter at one end, to similarly optimize fluid flow therethrough. It would have been obvious to one of ordinary skill in the art before the effective filing date for the device Gollner as modified by Aramaki, Dakin, Houser, Akin, and Tallarida have the cross-sectional shape of a lumen of a cylindrical portion which is different between one end portion of the cylindrical portion located along the first direction and the other end portion located on an opposite side of the one end portion, and the one end portion has a larger inner diameter than the other end portion in order to optimize fluid flow therethrough.
Claims 9, 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2009/0036820 to Dakin in view of U.S. Patent 8,361,092 to Asfora, U.S. Patent Publication 2003/0100920 to Akin, and U.S. Patent Publication 2003/0195504 to Tallarida as applied to claims 1, 2, 5-8, 10, 11, 14-17, 21, 25 above, and further in view of U.S. Patent 6,030,395 to Nash.
As to claims 9, 18, Dakin as modified by Asfora, Akin, and Tallarida discloses the device above but is silent a cross-sectional shape of a lumen of the cylindrical portion is different between one end portion of the cylindrical portion located along the first direction and the other end portion located on an opposite side of the one end portion, and the one end portion has a larger inner diameter than the other end portion.
Nash teaches a similar device (anastomosis device, abstract) having a having a cross-sectional shape of a lumen of a cylindrical portion (30) is different between one end portion of the cylindrical portion located along the first direction and the other end portion located on an opposite side of the one end portion (figure 1, 4, col. 6 ll. 44-54), and the one end portion has a larger inner diameter than the other end portion (figure 1, 4) for the purpose of reducing any turbulence in the flow therethrough (col. 6 ll. 44-54). It would have been obvious to one of ordinary skill in the art before the effective filing date for the device Dakin as modified by Asfora, Akin, and Tallarida have the cross-sectional shape of a lumen of a cylindrical portion which is different between one end portion of the cylindrical portion located along the first direction and the other end portion located on an opposite side of the one end portion, and the one end portion has a larger inner diameter than the other end portion in order to reduce any turbulence in the flow therethrough.
Claims 22, 23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0316426 to Gollner in view of U.S. Patent Publication 2019/0282235 to Aramaki and U.S. Patent Publication 2009/0036820 to Dakin, U.S. Patent Publication 2003/0100920 to Akin, U.S. Patent Publication 2003/0195504 to Tallarida and in view of and/or as evidenced by U.S Patent 7,182,771 to Houser as applied to claims 1, 2, 5, 6, 10, 11, 14, 15, 25 above, and further in view of U.S. Patent Publication 2003/0167064 to Whayne.
As to claims 22, 23, Gollner as modified by Aramaki, Dakin, Akin, Tallarida, and Houser discloses the device above but is silent about an outer peripheral portion of the cylindrical portion and the lumen of the cylindrical portion are circular shape, elliptical, or polygonal in shape.
Whayne teaches a similar device (connecting devices) having a lumen comprising are circular shape, elliptical, or polygonal in shape (paragraph 69) in order to form the pattern and shape as desired. It would have been obvious to one of ordinary skill in the art before the effective filing date to have an outer peripheral portion of the cylindrical portion and the lumen of the cylindrical portion Gollner as modified by Aramaki, Dakin, Akin, Tallarida, and Houser comprise circular shape, elliptical or polygonal in shape in in order for obtaining the desired shape as desired.
Claims 22, 23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2009/0036820 to Dakin in view of U.S. Patent 8,361,092 to Asfora, U.S. Patent Publication 2003/0100920 to Akin, and U.S. Patent Publication 2003/0195504 to Tallarida as applied to claims 1, 2, 5- 8, 10, 11, 14-17, 21, 25 above, and further in view of U.S. Patent Publication 2003/0167064 to Whayne.
As to claims 22, 23, Dakin as modified by Asfora, Akin and Tallarida discloses the device above but is silent about an outer peripheral portion of the cylindrical portion and the lumen of the cylindrical portion are circular shape, elliptical, or polygonal in shape.
Whayne teaches a similar device (connecting devices) having a lumen comprising are circular shape, elliptical, or polygonal in shape (paragraph 69) in order to form the pattern and shape as desired. It would have been obvious to one of ordinary skill in the art before the effective filing date to have an outer peripheral portion of the cylindrical portion and the lumen of the cylindrical portion Dakin as modified by Asfora, Akin and Tallarida comprise circular shape, elliptical or polygonal in shape in in order for obtaining the desired shape as desired.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 6,019,788 to Butters (materials), 6,503,258 to Filho (materials), U.S. Patent 8,002,744 to Pepper (welding), U.S. Patent Publication 2002/0116016 to Barath (materials), U.S. Patent Publication 2002/0116018 to Stevens (materials), U.S. Patent Publication 2003/0225425 to Kupiecki (materials), U.S. Patent Publication 2004/0044349 to Barry (materials), U.S. Patent Publication 2004/0087995 to Copa (materials), and U.S. Patent Publication 2007/0212559 to Shah (welding) all disclose similar subject matter capable of rendering obvious and/or providing evidence on the claims of record.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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